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Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial.

ABSTRACT: Recent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms.A three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique.The present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy of a specific technique or a pre-determined protocol.The protocol has been registered on ClinicalTrials.gov ( NCT02146677 ) on 20 May 2014.

SUBMITTER: Cerritelli F

PROVIDER: S-EPMC4362649 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial.

Cerritelli Francesco F Cicchitti Luca L Martelli Marta M Barlafante Gina G Renzetti Cinzia C Pizzolorusso Gianfranco G Lupacchini Mariacristina M D'Orazio Marianna M Marinelli Benedetta B Cozzolino Vincenzo V Fusilli Paola P D'Incecco Carmine C

Trials 20150308

<h4>Background</h4>Recent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in red ...[more]

PMID: 25872943

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Project description:BackgroundPatients with chronic low back pain (CLBP) suffer with functional, social, and psychological aspects. There is a growing number of studies with multimodal approaches in the management of these patients, combining physical and behavioral therapies such as osteopathic manipulative treatment, associating pain education and clinical hypnosis. The aim of the present study will be to evaluate the effects of osteopathic manipulative treatment (OMT) associated with pain neuroscience education (PNE) and clinical hypnosis (CH) on pain and disability in participants with CLBP compared to PNE, CH, and sham therapy.MethodsA randomized controlled clinical trial will be conducted in participants aged 20-60 years with CLBP who will be divided into two groups. Group 1 will receive PNE and CH associated with OMT, and G2 will receive PNE, CH, and sham therapy. In both groups, 4 interventions of a maximum of 50 min and with an interval of 7 days will be performed. As primary outcomes, pain (numerical pain scale), pressure pain threshold (pressure algometer), and disability (Oswestry Disability Questionnaire) will be evaluated and, as a secondary outcome, global impression of improvement (Percent of Improvement Scale), central sensitization (Central Sensitization Questionnaire), biopsychosocial aspects (Start Beck Toll Questionnaire), and behavior of the autonomic nervous system (heart rate variability) will be assessed. Participants will be evaluated in the pre-intervention moments, immediately after the end of the protocol and 4 weeks after the procedures. Randomization will be created through a simple randomized sequence and the evaluator will be blinded to the allocation of intervention groups.DiscussionThe guidelines have been encouraging multimodal, biopsychosocial approaches for patients with CLBP; in this sense, the results of this study can help clinicians and researchers in the implementation of a model of treatment strategy for these patients. In addition, patients may benefit from approaches with minimal risk of deleterious effects and low cost. In addition, it will enable the addition of relevant elements to the literature, with approaches that interact and do not segment the body and brain of patients with CLBP, allowing new studies in this scenario.Trials registrationDate: September 4, 2021/Number: NCT05042115 .

Project description:Osteopathic manipulative treatment (OMT) is a distinctive modality commonly used by osteopathic physicians to complement their conventional treatment of musculoskeletal disorders. Previous reviews and meta-analyses of spinal manipulation for low back pain have not specifically addressed OMT and generally have focused on spinal manipulation as an alternative to conventional treatment. The purpose of this study was to assess the efficacy of OMT as a complementary treatment for low back pain.Computerized bibliographic searches of MEDLINE, EMBASE, MANTIS, OSTMED, and the Cochrane Central Register of Controlled Trials were supplemented with additional database and manual searches of the literature. Six trials, involving eight OMT vs control treatment comparisons, were included because they were randomized controlled trials of OMT that involved blinded assessment of low back pain in ambulatory settings. Data on trial methodology, OMT and control treatments, and low back pain outcomes were abstracted by two independent reviewers. Effect sizes were computed using Cohen's d statistic and meta-analysis results were weighted by the inverse variance of individual comparisons. In addition to the overall meta-analysis, stratified meta-analyses were performed according to control treatment, country where the trial was conducted, and duration of follow-up. Sensitivity analyses were performed for both the overall and stratified meta-analyses.Overall, OMT significantly reduced low back pain (effect size, -0.30; 95% confidence interval, -0.47 - -0.13; P = .001). Stratified analyses demonstrated significant pain reductions in trials of OMT vs active treatment or placebo control and OMT vs no treatment control. There were significant pain reductions with OMT regardless of whether trials were performed in the United Kingdom or the United States. Significant pain reductions were also observed during short-, intermediate-, and long-term follow-up.OMT significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.

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Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial.

Publications

Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial.

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